Indications and uses
Temporarily relieves common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever
Coldtac Severe Cold Max Relief w/10 Softgels
- Manufacturer
- OPMX LLC
- Effective date
- 2026-10-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-10-09 01:01:23
Label at a glance#
ProductColdtac Severe Cold Max Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections
Dosage and administration
Take only as directed. Do not exceed 4 doses per 24 hours. Adults & children 12 yrs & over 2 softgels with water every 4 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredients (in each Softgel)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Purpose
- Pain reliever/Fever reducer
- Cough suppressant
Uses
Temporarily relieves common cold/flu symptoms:
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches and pains
- Fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 4 doses in 24 hrs, which is the maximum daily amount for this product.
- With other drugs containing acetaminophen.
- 3 or more alcoholic drinks daily while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin redding
- Blisters
- Rash
- If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- With any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson´s desease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- Liver disease
- Heart disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too much phlegm (mucus)
- Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are:
Taking the blood thinning drug warfarin.
When using this product,
do not use more than directed.
Stop use and ask a doctor if
- You get nervous, dizzy or sleepless.
- Symptoms get worse or last more than 5 days (children) or 7 days (adults).
- Fever gets worse or lasts more than 3 days.
- Redness or swelling is present.
- New symptoms occur.
- Cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
Keep out of reach of children.
If pregnant or breast-feeding,
ask a health professional before use.
Overdose warning:
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- Take only as directed.
- Do not exceed 4 doses per 24 hours.
| Adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| Children 4 to under 12 yrs | Ask a doctor |
| Children under 4 yrs | Do not use |
Other information
- Store at room temperature.
Inactive ingredients:
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.
Questions?
Call toll free 619-600-5632
Monday through Friday 9AM - 5PM EST
Distributed By
Made for:
RRX
San Diego, CA 92154
Exlusivley distributeed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69729-808-10
COLDTAC
SEVERE COLD
Acetaminophen 325mg / Dextromethorphan HBr 10mg
MAX RELIEF
Cold and Flu Relief:
Para el alivio de las molestias de la Gripe:
Headache & Sore Throat
Dolor de Cabeza y Garganta
Fever Reducer
Reduce la Fiebre
Cough Suppressant
Supresor de la Tos
10 Soft Gels
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0856828008649 | GTIN-13: 0856828008649 EAN-13: 0856828008649 GTIN-12: 856828008649 UPC-A: 856828008649 GTIN storage (14 digits): 00856828008649 | coldtac severe cold max relief_001.jpg |
| QR code link | QR Code |  opmx.us/ | coldtac severe cold max relief_001.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Coldtac Severe Cold Max Relief
- Acetaminohpen, Dextromethorphan Hydrobromide
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GLYCERIN
- TITANIUM DIOXIDE
- POVIDONE
- GELATIN
- FD&C YELLOW NO. 6
- PROPYLENE GLYCOL
- FD&C RED NO. 40
- SORBITOL
- WATER
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-808 | 69729-808-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| GELATIN | 2G86QN327L | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-01-29 | full-release | 2026-06-01 01:49:05 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Coldtac Severe Cold Max Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HYDROBROMIDE | OPMX LLC | 498ab6fd-09ab-b6a7-e063-6394a90a6790 | 2026-01-29 | Warnings | 69729-808-10 69729-808 69729080810 498ab6fd-09ab-b6a7-e063-6394a90a6790 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.